BEUDAMED
    FDA Adverse Event Summary report: N

    SIGMA

    MDR report key: 3193604 · Received June 22, 2013

    Report

    Report Number
    MW5030682
    Date Received
    June 22, 2013
    Date of Event
    October 4, 2010
    Report Date
    June 22, 2013
    Manufacturer
    DEPUY
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TOTAL KNEE REPLACEMENT DEPUY SIGMA CR 150 DONE BY (B)(6). AFTER TWO MONTHS OF PT 3/WK FLEXION WAS UNDER 90 DEGREES. HAD NON SURGICAL MANIPULATION IN (B)(6) IN (B)(6) WITH SAME SURGEON. PT FOLLOWED UNTIL (B)(6) 2011 WITH NO IMPROVEMENT OF FLEX. RETURN TO SURGEON IN (B)(6) 2011 TO UNDERGO ARTHROSCOPIC MANIPULATION OF KNEE. PT FOLLOWED FOR TWO MONTHS WITH LITTLE OR NO IMPROVEMENT. KNEE FUNCTION OK THROUGH 2012 WITH THE LIMITED FLEX BUT SMALL AMOUNT OF PAIN AND SWELLING. (B)(6) 2013, LOST 20 DEGREES OF FLEXION DOWN TO 68-70 DEGREES. INCREASED PAIN AND CONSTANT INFLAMMATION WITH LITTLE EXERTION. STOPPED MY 2 MILE WALK/DAY. CREPITUS NOTICED BILATERALLY BY (B)(6) HERE IN (B)(6). ALL ADVERSE CONDITIONS CONTINUE TO PRESENT. DR (B)(6) RETIRED ABOUT 15 MONTHS AFTER MY OPERATION. (B)(6) MERGED WITH PROLINE A LARGER BUSINESS WITH ABOUT 40 CLINICS IN (B)(6). SUBGROUP IS CALLED (B)(6). FORMER NAME IS NO LONGER BEING USED APPARENTLY. DR (B)(6) TOLD ME VIA PHONE THAT NO ONE IS FOLLOWING UP DIRECTLY WITH HIS PTS, BUT A DR (B)(6) HAS A SIMILAR BACKGROUND AND HAS FORMER PT'S FILES. (B)(6) 2010, (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284366 SIGMA CR 150 HSH DEPUY

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Disability